Is FDA Playing Politics with Drug Warnings?

March 24, 2005 — -- When LaDonna Williams had to remove every mirror in her house, she knew she was near the end of her rope.

"We had to take out all of the mirrors in our house because my daughter didn't want to see the monster, which was herself, on the other side," says Williams, whose daughter suffers from bleeding skin and itchy red patches caused by eczema.

"It was hard to watch as your kids don't get invited to all the fun activities concerning school, all because of how they looked," said Williams, executive director of the Inflammatory Skin Disease Institute in Newport News, Va.

Help came from two skin creams for eczema, Protopic and Elidel, which were introduced to the public in 2000 and 2001, respectively.

But the Food and Drug Administration recently announced that it will be adding a "black box warning" to the drugs after three animal studies showed they were associated with an increased risk of cancer.

Is the FDA overreacting? Many dermatologists think so -- and so do their patients.

Concerns Over Prescriptions for Children

The FDA warning came as an unpleasant surprise to eczema sufferers, many of whom have experienced great relief with the drugs. About 7 million to 8 million prescriptions have been written for Elidel and Protopic.

The FDA has received reports of lymphoma and skin cancer in children and adults treated with Elidel or Protopic. However, the agency has not yet determined whether these cancers exceeded the expected number of illnesses seen in any large group of people.

Several members of the FDA's Pediatric Advisory Committee declined to comment directly on the warning, but the FDA acknowledges that it may take more than 10 years of human studies to determine if the drugs' use is linked to cancer.

The committee initially recommended the warning labels due to concerns over the number of prescriptions for Elidel and Protopic that were being written for children.

Tim Warner, a spokesman for Fujisawa, the manufacturer of Protopic, said that the company would be working with the FDA to update the label's wording and to educate health care practitioners.

"What we don't want to happen is to have people with severe eczema to stop using the product completely without the direct orders from their doctors," said Warner.

Is the FDA Playing Politics?

Many dermatologists believe the FDA's warning is premature because there is no direct evidence that the creams cause cancer.

They believe the FDA is acting too quickly to compensate for its slow action in the recent political scandal involving the Cox-2 inhibitor painkillers Vioxx and Celebrex, which have been linked to heart attacks and strokes in some users.

"This is absurd beyond imagination -- not every drug is Vioxx; and the enormous evidence that was presented to the FDA demonstrated the safety of these [drugs]," said Dr. Mark Lebwohl, chairman of the department of dermatology at the Mount Sinai School of Medicine in New York.

Dr. Jon Hanifen, professor of dermatology at Oregon Health & Science University in Portland, believes that a "black box" warning is excessive and will only diminish the value of the warning that is already placed on both of these products.

"This is going to confuse physicians and negatively influence therapy," he said.

Dr. Han Lee, a dermatologist from the University of Southern California, echoes Hanifen's concerns.

"The options will now be limited for people who don't have many options for refractory eczema and for people using the drug for off-label purposes such as vitiligo and lichen planus, which are severe skin disorders," Lee said.

FDA Defends Its Position

However, with increasing numbers of prescriptions being written, many for children, the FDA denies that its warning is either rash or without merit.

"Whenever a product poses an increased risk of cancer for a chronic, but nonfatal disease, we need to underscore what the actual indications are for its use," says Dr. Sandra L. Kweder, deputy director of the FDA's Office of New Drugs.

Kweder believes that this warning will serve as a reminder to both clinicians and patients that Elidel and Protopic are "second line" drugs, intended for use only after initial or "first line" treatments fail.

But for people like Williams, the black label warning will not stop her children from taking the medications because they improved their quality of life.

"My daughter went from being the eczema girl to now being a girl with eczema -- that's a huge difference," she said.